Why chemical characterization is the best way to assess patient risk

Everyone is very familiar with the phrase when buying a house: All that really matters are three things - location, location, and location. This same principle applies to extractables and leachables chemistry analysis – the three things that truly matter are identification, identification, and identification. The greatest growth in the past ten years in demonstrating the safety of medical devices and container closure systems for drugs has been using analytical chemistry to determine what chemicals can leach from the device and what the patient is exposed to during its intended use.

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Stress Engineering Services, Inc.

At Stress Engineering Services we specialize in taking on your toughest technical problems because we understand that you don't just want answers; you want the right answers.Problem solving is what we do and what we deliver. It is our commitment to provide the most comprehensive design, analysis, and testing services with an unsurpassed level of engineering integrity and skill. This devotion to quality stems from the two basic principles on which the company was founded - technical excellence and a passion to serve.

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Chemical Technology

Key Trends in the Digital Transformation of the Chemical Industry

Article | August 8, 2022

The chemical business is intricate, with numerous sub-sectors dealing with various challenges. Thus, there are some differences in the sector's main areas of digitalization. For instance, while specialty chemicals with smaller batches but larger profit margins are concerned with improving quality, large factories are concentrated on accelerating throughput speed. To be able to react to quick and repeated changes in demand, supply, and working circumstances, however, every plant must optimize output, reduce waste, improve safety and sustainability, and become more nimble. Therefore, the Industrial Internet of Things (IIoT), artificial intelligence (AI), and cloud computing are expected to be the three most popular applications for digital transformation during the coming two years. Key Trends Production Optimization The first and most valuable use cases of digitalization in chemical plants center on production optimization through improved equipment performance, process automation, remote and predictive monitoring, and simplified maintenance. Chemical factories, which often provide basic chemicals for use as end products in other sectors, have a special responsibility to maintain consistently high product quality. However, doing so can be challenging given the significant variations in raw material supply and quality. In addition, as process engineers can change the mix on the fly in reaction to fluctuations in quality, feedstock, or ambient temperatures, better data and analytics enable finer and more frequent adjustments. Lowering Waste The main advantage of digitally transformed plants so far has been cost reduction. The price volatility of raw materials is a problem for the chemical production sector because customers naturally want constant low prices. Minimizing waste is critical since facilities must contend with rising energy costs. Analytics tools that monitor fluctuating raw material prices aid factories in negotiating the best deals with suppliers and preparing in advance for price spikes. The risk of oversupply is reduced since plants can prepare the proper quantities of various products thanks to more precise demand predictions. Sustainability, Compliance, and Safety The chemical industry is heavily regulated as a result of the quantity of hazardous chemicals and the number of end-use industries that rely on it. Businesses are adopting digital transformation to boost safety awareness, reduce emissions and dangerous flare incidents, and guarantee a transparent and accurate audit trail. Plants that quickly adopt digital solutions for remote monitoring, supply chain visibility, waste reduction, production optimization, raising their safety profile, and opening up new opportunities will profit from higher profits and increased revenue, whereas those that hesitate for too long risk failing in the long run.

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Chemical Technology

Future-Proofing the Chemical Industry with Digitalization

Article | August 2, 2022

Over the next five to seven years, the chemical sector will place a greater emphasis on sustainability, and digitization will play a significant part in this. Reducing resource use, pollution, energy consumption, and waste are some of its main applications. Additionally, it will increase demand for a circular economy supported by IoT, AI, and other digital technologies. Some of the systems now in place or being used in the sector include autonomous solutions that enable lower energy usage, dispatching systems for effective logistics and strategies for sustainable power and fuel consumption. Chemical players making the switch to digital platforms have a chance to triumph if they move swiftly and update their operational models in accordance with a few common success characteristics. In fact, according to our study, making the correct decisions can increase total earnings before interest, taxes, depreciation, and amortization by 3 percent or more (EBITDA). The Next Step of Operational Excellence The same level of transformation is available with digital technology for optimal performance, together with success-enabling measures. The same level of corporate participation and realignment will also be necessary for the effective implementation of digital technology. Finance and telecoms were early leaders in adopting digital technology faster than the chemical sector, which has just recently started to move in more significant numbers toward digitalization. A circular economy in the sector is also being enabled by the use and evaluation of digital technology. The "Right to Fix" movement is being driven by governments and legislators in Europe and the US, and small and medium-sized businesses in the industry are expected to invest in technology that makes it easier to repair electronic items with the least amount of waste. On a side note, by enabling the re-use of resources and products throughout the supply chain, digitalization with lean manufacturing (LM) would enable businesses to improve operational excellence and create value, thereby supporting the circular economy goal. Conclusion Given its extensive safety and regulatory requirements, the chemical sector has evolved slowly. However, as the global economy changes, some skills will become obsolete and others essential. The interconnectedness of people, processes, and technology, as well as the requirement for real-time insight at the levels closest to the action, are among the basic principles of Industry 4.0. These values have existed for some time and are an extension of our teams' current operational excellence initiatives. Digital transformation is not a technology endpoint but rather the following stage in the process and business evolution as the chemicals industry advances continuously.

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Chemical Management

Organic Catalyst Boasts Big Benefits

Article | July 13, 2021

An enzyme-mimicking catalyst opens a new route to important organic molecules such as glycolic acid and amino acids from pyruvate, report researchers in Japan. Moreover, the new catalyst is cheaper, more stable, safer and more environmentally friendly than conventional metal catalysts used in industry, they note, adding that it also displays the high enantioselectivity required by the pharmaceutical industry. “On top of these advantages, our newly developed organic catalyst system also promotes reactions using pyruvate that aren’t easily achievable using metal catalysts,” says Santanu Mondal, a PhD candidate in the chemistry and chemical bioengineering unit at Okinawa Institute of Science and Technology (OIST) Graduate University, Okinawa, Japan, and lead author of a study recently published in Organic Letters. “Organic catalysts, in particular, are set to revolutionize the industry and make chemistry more sustainable,” he stresses. The researchers use an acid and an amine mixture to force the pyruvate to act as an electron donor rather than its usual role as an electron receiver (Figure 1). Effectively mimicking how enzymes work, the amine binds to the pyruvate to make an intermediate molecule. The organic acid then covers up part of the intermediate molecule while leaving another part that can donate electrons free to react to form a new product. Currently, the organic catalyst system only works when reacting pyruvate with a specific class of organic molecule called cyclic imines. So, the researchers now are looking to develop a more-universal catalyst, i.e., one that can speed up reactions between pyruvate and a broad range of organic molecules. The challenge here is to try to make the electron-donating intermediate stage of pyruvate react with other functional groups such as aldehydes and ketones. However, different catalysts create different intermediates, all with different properties. For example, the enamine intermediate created by the researchers’ new reaction only reacts with cyclic imines. Their hypothesis, currently being investigated, is that creation of other intermediates such as an enolate, if possible, would achieve a broader pyruvate reactivity. In terms of cost, the researchers note that a palladium catalyst used in similar reactions is 25 times more expensive than their organic acid — which also is made from eco-friendly quinine. In addition, they believe scale-up of the process for industrial use definitely is possible. However, the researchers caution that the current amine-to-acid-catalyst loading ratio of 1:2 probably would need to be optimized for better results at a larger scale.

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Chemical Management

The supply-chain inflation threat to petrochemicals demand

Article | May 9, 2021

Petrochemicals themselves remain in short supply. This is partly because of reduced feedstock from refineries, a consequence of the pandemic-related collapse in transportation fuels demand.Global petrochemical supply is still edging back to something like normal following the US winter storms in February, during which most US capacity was shut down. A point of discussion is whether containers will become available in the right places at the right prices to relieve tightness in the European polyethylene (PE) market, once US supply has normalised. The container issue is making it difficult to move PE and polypropylene (PP) cargoes from Asia to Europe.Market intelligence from the US-based ICIS CDI team indicates that enough container freight space will be available to resume significant shipments of US PE to Europe, albeit at high prices. It will be several more weeks before domestic pipelines have been refilled, enabling US producers to refocus on exports, added CDI.

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Spotlight

Stress Engineering Services, Inc.

At Stress Engineering Services we specialize in taking on your toughest technical problems because we understand that you don't just want answers; you want the right answers.Problem solving is what we do and what we deliver. It is our commitment to provide the most comprehensive design, analysis, and testing services with an unsurpassed level of engineering integrity and skill. This devotion to quality stems from the two basic principles on which the company was founded - technical excellence and a passion to serve.

Related News

NGOs file suit over transparency of TSCA new chemicals programme

Chemical Watch | March 18, 2020

A coalition of NGOs has sued the US EPA over an alleged lack of transparency in the TSCA new chemicals programme, which "thwart[s] the ability of the public to be informed and to provide input". According to a complaint filed by five environmental nonprofits in federal court today, the EPA has operated its TSCA premanufacture review process in a "black box, denying the public information to which they are legally entitled". Having access to timely information, they contend, is necessary to ensure the members they represent "are able to provide input on the potential risks of new chemicals and the need for protections from those risks prior to completion of EPA’s reviews." And they therefore have asked the court to ensure that the EPA complies with TSCA’s disclosure provisions, including by requiring that it:

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ACC to Trump, governors: Keep chemical industry going during coronavirus crisis

S&P Global | March 18, 2020

The US chemical industry's trade group told President Donald Trump and state governors this week that its sector must maintain operations as the coronavirus outbreak spreads to ensure supply of chemicals needed for disinfectants, plastics for food preservation and medical equipment, and staples like diapers and soap. "The role of chemistry is particularly important today, as chemicals enable countless products that will be needed to support good hygiene and treat those who are infected with the coronavirus in the weeks and months ahead," American Chemistry Council President and CEO Chris Jahn said in a letter to Trump and governors late Tuesday. Efforts to hinder the spread of coronavirus have included cancellations of major sporting events, concerts, conferences, parades, and other large gatherings, as well as closures of bars and limiting restaurants to takeout and deliveries. Companies have increasingly sent employees to work from their homes, while hospitals, grocery stores, and drug stores work to keep up with demand for care and products.

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How small chemical company leaders are dealing with the coronavirus

C&EN | March 17, 2020

As measures to contain the coronavirus—SARS-CoV-2—sweep across the US, the heads of privately owned chemical and instrument companies find themselves in uncharted territory trying to keep their companies going and their employees safe. C&EN reached out to CEOs of several such firms to learn what they are doing to keep business moving forward. We heard stories about setbacks, as expected supplies didn’t come through, but also small triumphs, as needed safety equipment was finally found. Overall, these leaders are keeping a close eye on supplies while planning for the real possibility that orders will drop in the coming months. Keeping staff healthy and maintaining continuity in customer service are the top priorities at Boron Specialties. “We are a pretty small facility, seven people &on-site&, so as best as we can we’re isolating,” CEO and founder Beth Bosley says.

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NGOs file suit over transparency of TSCA new chemicals programme

Chemical Watch | March 18, 2020

A coalition of NGOs has sued the US EPA over an alleged lack of transparency in the TSCA new chemicals programme, which "thwart[s] the ability of the public to be informed and to provide input". According to a complaint filed by five environmental nonprofits in federal court today, the EPA has operated its TSCA premanufacture review process in a "black box, denying the public information to which they are legally entitled". Having access to timely information, they contend, is necessary to ensure the members they represent "are able to provide input on the potential risks of new chemicals and the need for protections from those risks prior to completion of EPA’s reviews." And they therefore have asked the court to ensure that the EPA complies with TSCA’s disclosure provisions, including by requiring that it:

Read More

ACC to Trump, governors: Keep chemical industry going during coronavirus crisis

S&P Global | March 18, 2020

The US chemical industry's trade group told President Donald Trump and state governors this week that its sector must maintain operations as the coronavirus outbreak spreads to ensure supply of chemicals needed for disinfectants, plastics for food preservation and medical equipment, and staples like diapers and soap. "The role of chemistry is particularly important today, as chemicals enable countless products that will be needed to support good hygiene and treat those who are infected with the coronavirus in the weeks and months ahead," American Chemistry Council President and CEO Chris Jahn said in a letter to Trump and governors late Tuesday. Efforts to hinder the spread of coronavirus have included cancellations of major sporting events, concerts, conferences, parades, and other large gatherings, as well as closures of bars and limiting restaurants to takeout and deliveries. Companies have increasingly sent employees to work from their homes, while hospitals, grocery stores, and drug stores work to keep up with demand for care and products.

Read More

How small chemical company leaders are dealing with the coronavirus

C&EN | March 17, 2020

As measures to contain the coronavirus—SARS-CoV-2—sweep across the US, the heads of privately owned chemical and instrument companies find themselves in uncharted territory trying to keep their companies going and their employees safe. C&EN reached out to CEOs of several such firms to learn what they are doing to keep business moving forward. We heard stories about setbacks, as expected supplies didn’t come through, but also small triumphs, as needed safety equipment was finally found. Overall, these leaders are keeping a close eye on supplies while planning for the real possibility that orders will drop in the coming months. Keeping staff healthy and maintaining continuity in customer service are the top priorities at Boron Specialties. “We are a pretty small facility, seven people &on-site&, so as best as we can we’re isolating,” CEO and founder Beth Bosley says.

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